Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies

N/ACompletedNCT03200041

Premaitha Health1,000 enrolled

Overview

The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.

350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

1,000

Conditions

Down Syndrome Patau Syndrome Edward's Syndrome

Interventions

Blood samplePROCEDURE

20 ml blood sample taken from vein in arm

Eligibility

Sex: FEMALEMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Currently pregnant with twin foetuses at time of entry to study * Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT) * If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping. Exclusion Criteria: * Participant herself has down syndrome or other chromosomal abnormality

Locations (1)

Premaitha Health

Manchester, United Kingdom

Outcomes

Primary Outcomes

Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.

IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.

Time frame: 18 months

Data from ClinicalTrials.gov

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